11.100.20 : Biological evaluation of medical devices
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DIN EN ISO 10993-4/A1:2024-04
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1 (ISO 10993-4:2017/DAM 1:2024), German and English version EN ISO 10993-4:2017/prA1:2024
4/1/2024 - PDF - English, German -
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DIN EN ISO 7405:2024-04
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO/DIS 7405:2024), German and English version prEN ISO 7405:2024
4/1/2024 - PDF - English, German -
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DIN EN ISO 10993-17:2024-02
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023), German version EN ISO 10993-17:2023
2/1/2024 - PDF - German -
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DIN EN ISO 10993-18:2023-11
Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020 + Amd 1:2022), German version EN ISO 10993-18:2020 + A1:2023
11/1/2023 - PDF - German -
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DIN EN ISO 10993-15:2023-07
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019), German version EN ISO 10993-15:2023
7/1/2023 - PDF - German -
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DIN EN ISO 10993-10:2023-04
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021), German version EN ISO 10993-10:2023
4/1/2023 - PDF - German -
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DIN EN ISO 10993-2:2023-02
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022), German version EN ISO 10993-2:2022
2/1/2023 - PDF - German -
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DIN EN ISO 10993-7:2022-09
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019), German version EN ISO 10993-7:2008 + AC:2009 + A1:2022
9/1/2022 - PDF - German -
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DIN EN ISO 20776-2:2022-04
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021), German version EN ISO 20776-2:2022
4/1/2022 - PDF - German -
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DIN EN ISO 10993-9:2022-03
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019), German version EN ISO 10993-9:2021
3/1/2022 - PDF - German -
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DIN EN ISO 10993-23:2021-10
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021), German version EN ISO 10993-23:2021
10/1/2021 - PDF - German -
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DIN EN ISO 22442-1:2021-08
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020), German version EN ISO 22442-1:2020.
8/1/2021 - PDF - German -
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DIN EN ISO 10993-12:2021-08
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021), German version EN ISO 10993-12:2021
8/1/2021 - PDF - German -
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DIN EN ISO 10993-1:2021-05
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10), German version EN ISO 10993-1:2020
5/1/2021 - PDF - German -
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DIN EN ISO 14155:2021-05
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020), German version EN ISO 14155:2020
5/1/2021 - PDF - German -
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DIN EN ISO 22442-2:2021-04
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020), German version EN ISO 22442-2:2020
4/1/2021 - PDF - German -
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DIN EN ISO 20776-1:2020-12
Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12), German version EN ISO 20776-1:2020
12/1/2020 - PDF - German -
Learn More€85.79 -
DIN EN ISO 7405:2019-03
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2018, Corrected version 2018-12), German version EN ISO 7405:2018
3/1/2019 - PDF - German -
Learn More€126.26 -
DIN EN ISO 10993-11:2018-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017), German version EN ISO 10993-11:2018
9/1/2018 - PDF - German -
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DIN EN ISO 10993-11:2018-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
9/1/2018 - PDF - English -
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DIN EN ISO 10993-16:2018-02
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
2/1/2018 - PDF - English -
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DIN EN ISO 10993-16:2018-02
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017), German version EN ISO 10993-16:2017
2/1/2018 - PDF - German -
Learn More€85.79 -
DIN EN ISO 10993-4:2017-12
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
12/1/2017 - PDF - English -
Learn More€230.75 -
DIN EN ISO 10993-4:2017-12
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017), German version EN ISO 10993-4:2017
12/1/2017 - PDF - German -
Learn More€184.58 -
DIN EN ISO 10993-6:2017-09
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016), German version EN ISO 10993-6:2016
9/1/2017 - PDF - German -
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DIN EN ISO 10993-6:2017-09
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
9/1/2017 - PDF - English -
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DIN EN ISO 10993-3:2015-02
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
2/1/2015 - PDF - English -
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DIN EN ISO 10993-3:2015-02
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014), German version EN ISO 10993-3:2014
2/1/2015 - PDF - German -
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DIN ISO 13022:2014-06
Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
6/1/2014 - PDF - English -
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DIN ISO 13022:2014-06
Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
6/1/2014 - PDF - German -
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DIN EN ISO 10993-13:2010-11
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010), German version EN ISO 10993-13:2010
11/1/2010 - PDF - German -
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DIN EN ISO 10993-13:2010-11
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
11/1/2010 - PDF - English -
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DIN EN ISO 10993-5:2009-10
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009), German version EN ISO 10993-5:2009
10/1/2009 - PDF - German -
Learn More€115.33 -
DIN EN ISO 10993-5:2009-10
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
10/1/2009 - PDF - English -
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DIN EN ISO 10993-14:2009-08
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001), German version EN ISO 10993-14:2009.
8/1/2009 - PDF - German -
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DIN EN ISO 10993-14:2009-08
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
8/1/2009 - PDF - English -
Learn More€99.44